Allergan and Native American tribe take on Amneal for patent infringement

US-based Allergan and the Saint Regis Mohawk Tribe have accused pharmaceutical company Amneal of infringing two patents in its generic version of an eye treatment.

The claim was filed at the US District Court for the District of Delaware on Thursday, September 20.

The two patents relate to Allergan’s treatment for chronic dry eye, Restasis (cyclosporine ophthalmic emulsion).

In 2017, Allergan caused a stir in the pharmaceutical industry after paying the Saint Regis Mohawk Tribe $13.75 million to acquire patents for the treatment.

Mylan, which had filed inter partes reviews (IPRs) against six patents for Restasis, criticised Allergan for trying to delay the process.

The two patents in the latest case, which are now assigned to the tribe, are called “Methods of providing therapeutic effects using cyclosporin components” (US numbers 8,633,162 and 8,642,556).

The ‘162 and ‘556 inventions are two of the six patents that were named in the IPRs.

According to the claim, Amneal submitted Abbreviated New Drug Application (ANDA) number 211,909 requesting US Food and Drug Administration (FDA) approval to begin manufacturing a generic version of Restasis.

Allergan and the tribe alleged that in its ANDA application, Amneal said the claims of the two patents covering Restasis are invalid, unenforceable and would not be infringed if the company was given permission to manufacture a generic version.

The suit added that although the FDA has not yet approved Amneal’s ANDA, the company is still pursuing approval.

“On information and belief, Amneal has made, and continues to make, substantial preparation in the US to manufacture, offer to sell, sell, and/or import a generic version of Allergan’s Restasis product before expiration of the patents-in-suit,” said the claim.

Allergan and the Saint Regis Mohawk Tribe have asked the court to find the patents valid and enforceable, and have sought an injunction against Amneal plus damages.

The Allergan and tribe deal has been no stranger to scrutiny.

In February 2018, the Patent Trial and Appeal Board (PTAB) rejected the Saint Regis Mohawk Tribe’s attempt to dismiss the IPRs based on the tribe’s immunity claims after Allergan attempted to remove itself from the IPRs.

However, the PTAB said that Allergan retained ownership in the patents and that tribal immunity does not apply in IPR proceedings.

The US Court of Appeals for the Federal Circuit dismissed Allergan’s and the tribe’s appeal in July.

Earlier this month, the US states of Indiana, Hawaii, Illinois, Massachusetts, Texas, Utah and Virginia urged the Federal Circuit to rehear its decision rejecting the use of tribal sovereign immunity in the IPR process.

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